Z-0258-2013 Class II Terminated
FDA device recall Z-0258-2013 was initiated by Kimberly-Clark Corporation on July 5, 2012 and is designated Class II. Reason for recall: Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled. The recall status is terminated (terminated June 13, 2013). Affected quantity: 933 ((30 units per case).
Recall Details
- Product Type
- Devices
- Report Date
- November 14, 2012
- Initiation Date
- July 5, 2012
- Termination Date
- June 13, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 933 ((30 units per case)
Product Description
MicroCool Breathable Gown with Towels, X-Larg, X-Long, Sterile The product is a sterile, single use, surgical gown intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material.
Reason for Recall
Package seam of some units may not remain properly sealed to ensure the contents might not be sterile as labeled.
Distribution Pattern
Nationwide Distribution
Code Information
Product Code 92042 - All lot numbers beginning with: AH9282*** to AH9309***, AH0013*** to AH0329***, AH1020 *** to AH1293***, AH2019*** to AH2175***